MDedge Psychiatry

Adjunctive pimavanserin brought clinically meaningful improvement in patients with anxious major depressive disorder inadequately responsive to standard antidepressants alone in a post hoc analysis of the CLARITY trial, Bryan Dirks, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

This is an intriguing observation, because it’s estimated that roughly 50% of individuals with major depressive disorder (MDD) have comorbid anxiety disorders or a high level of anxiety symptoms. Moreover, anxious depression has been associated with increased risk of suicidality, high unemployment, and impaired functioning.

CLARITY was a phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial whose positive results for the primary outcome have been published (J Clin Psychiatry. 2019 Sep 24;80[6]:19m12928. doi: 10.4088/JCP.19m12928). Because the encouraging findings regarding pimavanserin’s impact on anxious depression came from a post hoc analysis, the results need replication. That’s ongoing in a phase 3 trial of adjunctive pimavanserin versus placebo in patients with MDD, according to Dr. Dirks, director of clinical research at Acadia Pharmaceuticals, San Diego.

The CLARITY post hoc analysis included 104 patients with baseline MDD inadequately responsive to an SSRI or a serotonin norepinephrine reuptake inhibitor and anxious depression as defined by a Hamilton Depression Rating Scale (HAMD-17) anxiety/somatization factor subscale score of 7 or more. Twenty-nine of the patients were randomized to 34 mg of adjunctive oral pimavanserin once daily, and 75 to placebo. At 5 weeks, the HAMD-17 anxiety/somatization factor score in the pimavanserin group had dropped by a mean of 5 points from a baseline of 8.8, a significantly greater effect than the 2.8-point drop in placebo-treated controls.

By week 5, the treatment response rate as defined by at least a 50% reduction in HAMD-17 total score from baseline was 55% with pimavanserin and 22% with placebo. The remission rate as indicated by a HAMD-17 total score below 7 was 24% in the pimavanserin group, compared with 5% with placebo. These results translated into an effect size of 0.78, considered by statisticians to be on the border between medium and large. Those response and remission rates in patients with anxious depression were higher with pimavanserin and lower with placebo than in the overall CLARITY trial.

The impact of adjunctive pimavanserin on top of a background SSRI or SNRI was even more pronounced in the subgroup of patients with baseline severe MDD as defined by a HAMD-17 total score of 24 or more plus an anxiety/somatization factor score of 7 or greater. Seventeen such patients were randomized to adjunctive pimavanserin, 36 to placebo. At 5 weeks, the mean HAMD total score had dropped by 17.4 points from a baseline of 27.6 in the pimavanserin group, compared with a 9.3-point reduction in controls.

“Of note, significant differences from placebo were observed as early as week 2 with pimavanserin,” Dr. Dirks said.

Pimavanserin is a novel selective serotonin inverse agonist with a high affinity for 5-HT2A receptors and low affinity for 5-HT2C receptors. At present pimavanserin is Food Drug Administration–approved as Nuplazid only for treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, but because of the drug’s unique mechanism of action it is under study for a variety of other mental disorders. Indeed, pimavanserin is now under FDA review for a possible expanded indication for treatment of dementia-related psychosis. The drug is also under study for schizophrenia as well as for MDD.

The CLARITY trial and this post hoc analysis were sponsored by Acadia Pharmaceuticals.

[email protected]

SOURCE: Dirks B. ECNP 2020. Abstract P 094.

Adjunctive pimavanserin brought clinically meaningful improvement in patients with anxious major depressive disorder inadequately responsive to standard antidepressants alone in a post hoc analysis of the CLARITY trial, Bryan Dirks, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

This is an intriguing observation, because it’s estimated that roughly 50% of individuals with major depressive disorder (MDD) have comorbid anxiety disorders or a high level of anxiety symptoms. Moreover, anxious depression has been associated with increased risk of suicidality, high unemployment, and impaired functioning.

CLARITY was a phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial whose positive results for the primary outcome have been published (J Clin Psychiatry. 2019 Sep 24;80[6]:19m12928. doi: 10.4088/JCP.19m12928). Because the encouraging findings regarding pimavanserin’s impact on anxious depression came from a post hoc analysis, the results need replication. That’s ongoing in a phase 3 trial of adjunctive pimavanserin versus placebo in patients with MDD, according to Dr. Dirks, director of clinical research at Acadia Pharmaceuticals, San Diego.

The CLARITY post hoc analysis included 104 patients with baseline MDD inadequately responsive to an SSRI or a serotonin norepinephrine reuptake inhibitor and anxious depression as defined by a Hamilton Depression Rating Scale (HAMD-17) anxiety/somatization factor subscale score of 7 or more. Twenty-nine of the patients were randomized to 34 mg of adjunctive oral pimavanserin once daily, and 75 to placebo. At 5 weeks, the HAMD-17 anxiety/somatization factor score in the pimavanserin group had dropped by a mean of 5 points from a baseline of 8.8, a significantly greater effect than the 2.8-point drop in placebo-treated controls.

By week 5, the treatment response rate as defined by at least a 50% reduction in HAMD-17 total score from baseline was 55% with pimavanserin and 22% with placebo. The remission rate as indicated by a HAMD-17 total score below 7 was 24% in the pimavanserin group, compared with 5% with placebo. These results translated into an effect size of 0.78, considered by statisticians to be on the border between medium and large. Those response and remission rates in patients with anxious depression were higher with pimavanserin and lower with placebo than in the overall CLARITY trial.

The impact of adjunctive pimavanserin on top of a background SSRI or SNRI was even more pronounced in the subgroup of patients with baseline severe MDD as defined by a HAMD-17 total score of 24 or more plus an anxiety/somatization factor score of 7 or greater. Seventeen such patients were randomized to adjunctive pimavanserin, 36 to placebo. At 5 weeks, the mean HAMD total score had dropped by 17.4 points from a baseline of 27.6 in the pimavanserin group, compared with a 9.3-point reduction in controls.

“Of note, significant differences from placebo were observed as early as week 2 with pimavanserin,” Dr. Dirks said.

Pimavanserin is a novel selective serotonin inverse agonist with a high affinity for 5-HT2A receptors and low affinity for 5-HT2C receptors. At present pimavanserin is Food Drug Administration–approved as Nuplazid only for treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, but because of the drug’s unique mechanism of action it is under study for a variety of other mental disorders. Indeed, pimavanserin is now under FDA review for a possible expanded indication for treatment of dementia-related psychosis. The drug is also under study for schizophrenia as well as for MDD.

The CLARITY trial and this post hoc analysis were sponsored by Acadia Pharmaceuticals.

[email protected]

SOURCE: Dirks B. ECNP 2020. Abstract P 094.

Adjunctive pimavanserin brought clinically meaningful improvement in patients with anxious major depressive disorder inadequately responsive to standard antidepressants alone in a post hoc analysis of the CLARITY trial, Bryan Dirks, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

This is an intriguing observation, because it’s estimated that roughly 50% of individuals with major depressive disorder (MDD) have comorbid anxiety disorders or a high level of anxiety symptoms. Moreover, anxious depression has been associated with increased risk of suicidality, high unemployment, and impaired functioning.

CLARITY was a phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial whose positive results for the primary outcome have been published (J Clin Psychiatry. 2019 Sep 24;80[6]:19m12928. doi: 10.4088/JCP.19m12928). Because the encouraging findings regarding pimavanserin’s impact on anxious depression came from a post hoc analysis, the results need replication. That’s ongoing in a phase 3 trial of adjunctive pimavanserin versus placebo in patients with MDD, according to Dr. Dirks, director of clinical research at Acadia Pharmaceuticals, San Diego.

The CLARITY post hoc analysis included 104 patients with baseline MDD inadequately responsive to an SSRI or a serotonin norepinephrine reuptake inhibitor and anxious depression as defined by a Hamilton Depression Rating Scale (HAMD-17) anxiety/somatization factor subscale score of 7 or more. Twenty-nine of the patients were randomized to 34 mg of adjunctive oral pimavanserin once daily, and 75 to placebo. At 5 weeks, the HAMD-17 anxiety/somatization factor score in the pimavanserin group had dropped by a mean of 5 points from a baseline of 8.8, a significantly greater effect than the 2.8-point drop in placebo-treated controls.

By week 5, the treatment response rate as defined by at least a 50% reduction in HAMD-17 total score from baseline was 55% with pimavanserin and 22% with placebo. The remission rate as indicated by a HAMD-17 total score below 7 was 24% in the pimavanserin group, compared with 5% with placebo. These results translated into an effect size of 0.78, considered by statisticians to be on the border between medium and large. Those response and remission rates in patients with anxious depression were higher with pimavanserin and lower with placebo than in the overall CLARITY trial.

The impact of adjunctive pimavanserin on top of a background SSRI or SNRI was even more pronounced in the subgroup of patients with baseline severe MDD as defined by a HAMD-17 total score of 24 or more plus an anxiety/somatization factor score of 7 or greater. Seventeen such patients were randomized to adjunctive pimavanserin, 36 to placebo. At 5 weeks, the mean HAMD total score had dropped by 17.4 points from a baseline of 27.6 in the pimavanserin group, compared with a 9.3-point reduction in controls.

“Of note, significant differences from placebo were observed as early as week 2 with pimavanserin,” Dr. Dirks said.

Pimavanserin is a novel selective serotonin inverse agonist with a high affinity for 5-HT2A receptors and low affinity for 5-HT2C receptors. At present pimavanserin is Food Drug Administration–approved as Nuplazid only for treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, but because of the drug’s unique mechanism of action it is under study for a variety of other mental disorders. Indeed, pimavanserin is now under FDA review for a possible expanded indication for treatment of dementia-related psychosis. The drug is also under study for schizophrenia as well as for MDD.

The CLARITY trial and this post hoc analysis were sponsored by Acadia Pharmaceuticals.

[email protected]

SOURCE: Dirks B. ECNP 2020. Abstract P 094.

A COVID-19 vaccine could be proven effective within the last months of 2020, with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.

“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”

If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.

Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.

He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.

Rapid development gives reason for hope

Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.

“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”

“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”

COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.

Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.

As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.

Prioritizing COVID-19 vaccine distribution

Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.

Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.

COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.

Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.

Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.

[email protected]

A COVID-19 vaccine could be proven effective within the last months of 2020, with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.

“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”

If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.

Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.

He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.

Rapid development gives reason for hope

Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.

“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”

“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”

COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.

Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.

As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.

Prioritizing COVID-19 vaccine distribution

Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.

Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.

COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.

Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.

Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.

[email protected]

A COVID-19 vaccine could be proven effective within the last months of 2020, with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.

“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”

If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.

Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.

He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.

Rapid development gives reason for hope

Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.

“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”

“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”

COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.

Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.

As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.

Prioritizing COVID-19 vaccine distribution

Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.

Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.

COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.

Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.

Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.

[email protected]

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Adam is a 14-year-old who presents for “behavioral concerns” as recommended by his teacher. He is in the eighth grade and is struggling academically and socially. He has intermittent outbursts and poor engagement with other children, and often refuses to do schoolwork. He is seen in the outpatient primary care clinic, usually with his mother and two older siblings, one of whom typically translates for his Arabic-speaking mother. Adam is bilingual, although he prefers Arabic. It is difficult to understand the presenting concern as Adam states that he is doing well and is unsure why the teacher would have made such a report. Mother notes that she does not see these behaviors at home either.

What must we consider? Are there potential barriers, alternate ways to engage, and what role may culture have?

There are many things to consider in the above case, including language barriers, nuanced interactions, and cultural expectations and norms. To understand the scope, statistics reveal that the United States leads the world in its immigrant population with about 44.8 million foreign-born persons in 2018, which accounts for approximately 13.7% of the U.S. population.¹ In 2019, 30,000 refugees were resettled in the United States.² In 2017, immigrant children made up 27% (19.6 million) of U.S. children, of which second-generation children (born in the United States to immigrant parents) were the vast majority at 16.7 million.³ Given this information, it is self-evident that we live in a multicultural society; it is imperative to consider the cultural context in which our patients and families are presenting.

FatCamera/E+

Culture is defined as a set of shared beliefs, norms, values, and behaviors exhibited by a group. Culture plays a role and impacts children in various ways throughout their development. Health care providers would benefit from aspiring to exude cultural humility – learning with and from patients and their families with openness, kindness, and a desire for collaboration. The provider also must consider a family’s history of migration as the response to migration may vary based on age, personal experiences, age at which migration occurred, language abilities, and amount of cultural engagement in the new country (i.e. acculturation).^4,5
 

Cultural framework model

One example of a potential framework to use to engage within a cultural context includes the LEARN (Listen, Explain, Acknowledge, Recommend, Negotiate) model,^6,7 which initially was developed to be used within a family medicine clinic. It includes the following:

Listen with sympathy and understanding to the patient’s perception of the problem. Try to understand their perspective of symptoms through considering their thoughts regarding etiology and treatment options.

Explain your perception of the problem. Have a dialogue about what you perceive is the likely cause based on a medical perspective.

Acknowledge and discuss the differences and similarities. Engage in open conversation while being cognizant that there may be similarities and differences in the perception you may have versus your patient’s perception. Try to find areas that can be engaged in and an alliance built upon, as well as respectfully and humbly addressing any concerns about potentially harmful patient understandings.

Recommend treatment. Present a treatment recommendation that considers both yours and the patient’s perspectives.

Negotiate agreement. Discuss, collaborate, and finalize a treatment plan that considers a biopsychosocial and spiritual/religious model of care that is patient-centered and personalized such that the main goal is optimal health and wellness for the patient/family.

The following are tips to consider in the life-long process of becoming more culturally aware:

• Be willing to learn with your patients and be thoughtful about your own feelings/thoughts/behaviors that may be positively or negatively impacting those interactions.
• Be aware of your own identity and what that may contribute to the clinical space.
• Recognize that you are not meant to know everything, but being open to the journey and learning process will go a long way.
• Try to shift the focus from paternalistic medicine to collaborative and patient-centered approaches.

The case at hand

In returning to our case and applying the LEARN model and cultural humility, we may be able to uncover more of the story. Adam is seen at a subsequent appointment, and you determine it best to obtain an in-person interpreter for this appointment. As you listen to the story, you learn that his father was killed early in Adam’s life, his mother has suffered from depression, and they moved here 3 years ago from a refugee camp, where most of their family continues to reside. He notes that at times he feels that he is back in that space and that he also feels frustrated. He is accustomed to doing well academically, but English has been difficult to learn.

You explain your understanding and acknowledge concerns for his past experiences playing a role, the importance of having community supports, and that learning a new language is challenging. You recommend that the school offer culturally appropriate interventions, trauma-informed assessments, and English-language opportunities. Adam and his mother note willingness to engage in this plan but would like to speak to their local religious leader as well.

Collaborating in a manner similar to this will likely build a therapeutic alliance between the patient, their family, and caretakers, thus leading to improved outcomes.

For further reading, consider AACAP Finding Mental Healthcare for Children of Immigrants and the American Academy of Pediatrics Providing Culturally Effective Care Toolkit.
 

Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. “Key findings about U.S. immigrants.” Pew Research Center, Washington, D.C. (2020)

2. “Key facts about refugees to the U.S.” Pew Research Center, Washington, D.C. (2019)

3. “Immigrant Children.” Child Trends, Bethesda, MD (2018).

4. Kaplan & Sadock’s Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry, 11th ed. (Philadelphia: Lippincott Williams & Wilkins, 2015, pp. 139-45).

5. Lewis’sChild and Adolescent Psychiatry: A Comprehensive Textbook, 5th ed. (Philadelphia: Lippincott Williams & Wilkins, 2017, pp. 111-22).

6. Berlin EA, Fowkes WA Jr.A teaching framework for cross-cultural health care. Application in family practice. West J Med 1983;139(6):934-8.

7. Paediatr Child Health. 2018 Feb;23(1):66-9.

Adam is a 14-year-old who presents for “behavioral concerns” as recommended by his teacher. He is in the eighth grade and is struggling academically and socially. He has intermittent outbursts and poor engagement with other children, and often refuses to do schoolwork. He is seen in the outpatient primary care clinic, usually with his mother and two older siblings, one of whom typically translates for his Arabic-speaking mother. Adam is bilingual, although he prefers Arabic. It is difficult to understand the presenting concern as Adam states that he is doing well and is unsure why the teacher would have made such a report. Mother notes that she does not see these behaviors at home either.

What must we consider? Are there potential barriers, alternate ways to engage, and what role may culture have?

There are many things to consider in the above case, including language barriers, nuanced interactions, and cultural expectations and norms. To understand the scope, statistics reveal that the United States leads the world in its immigrant population with about 44.8 million foreign-born persons in 2018, which accounts for approximately 13.7% of the U.S. population.¹ In 2019, 30,000 refugees were resettled in the United States.² In 2017, immigrant children made up 27% (19.6 million) of U.S. children, of which second-generation children (born in the United States to immigrant parents) were the vast majority at 16.7 million.³ Given this information, it is self-evident that we live in a multicultural society; it is imperative to consider the cultural context in which our patients and families are presenting.

FatCamera/E+

Culture is defined as a set of shared beliefs, norms, values, and behaviors exhibited by a group. Culture plays a role and impacts children in various ways throughout their development. Health care providers would benefit from aspiring to exude cultural humility – learning with and from patients and their families with openness, kindness, and a desire for collaboration. The provider also must consider a family’s history of migration as the response to migration may vary based on age, personal experiences, age at which migration occurred, language abilities, and amount of cultural engagement in the new country (i.e. acculturation).^4,5
 

Cultural framework model

One example of a potential framework to use to engage within a cultural context includes the LEARN (Listen, Explain, Acknowledge, Recommend, Negotiate) model,^6,7 which initially was developed to be used within a family medicine clinic. It includes the following:

Listen with sympathy and understanding to the patient’s perception of the problem. Try to understand their perspective of symptoms through considering their thoughts regarding etiology and treatment options.

Explain your perception of the problem. Have a dialogue about what you perceive is the likely cause based on a medical perspective.

Acknowledge and discuss the differences and similarities. Engage in open conversation while being cognizant that there may be similarities and differences in the perception you may have versus your patient’s perception. Try to find areas that can be engaged in and an alliance built upon, as well as respectfully and humbly addressing any concerns about potentially harmful patient understandings.

Recommend treatment. Present a treatment recommendation that considers both yours and the patient’s perspectives.

Negotiate agreement. Discuss, collaborate, and finalize a treatment plan that considers a biopsychosocial and spiritual/religious model of care that is patient-centered and personalized such that the main goal is optimal health and wellness for the patient/family.

The following are tips to consider in the life-long process of becoming more culturally aware:

• Be willing to learn with your patients and be thoughtful about your own feelings/thoughts/behaviors that may be positively or negatively impacting those interactions.
• Be aware of your own identity and what that may contribute to the clinical space.
• Recognize that you are not meant to know everything, but being open to the journey and learning process will go a long way.
• Try to shift the focus from paternalistic medicine to collaborative and patient-centered approaches.

The case at hand

In returning to our case and applying the LEARN model and cultural humility, we may be able to uncover more of the story. Adam is seen at a subsequent appointment, and you determine it best to obtain an in-person interpreter for this appointment. As you listen to the story, you learn that his father was killed early in Adam’s life, his mother has suffered from depression, and they moved here 3 years ago from a refugee camp, where most of their family continues to reside. He notes that at times he feels that he is back in that space and that he also feels frustrated. He is accustomed to doing well academically, but English has been difficult to learn.

You explain your understanding and acknowledge concerns for his past experiences playing a role, the importance of having community supports, and that learning a new language is challenging. You recommend that the school offer culturally appropriate interventions, trauma-informed assessments, and English-language opportunities. Adam and his mother note willingness to engage in this plan but would like to speak to their local religious leader as well.

Collaborating in a manner similar to this will likely build a therapeutic alliance between the patient, their family, and caretakers, thus leading to improved outcomes.

For further reading, consider AACAP Finding Mental Healthcare for Children of Immigrants and the American Academy of Pediatrics Providing Culturally Effective Care Toolkit.
 

Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. “Key findings about U.S. immigrants.” Pew Research Center, Washington, D.C. (2020)

2. “Key facts about refugees to the U.S.” Pew Research Center, Washington, D.C. (2019)

3. “Immigrant Children.” Child Trends, Bethesda, MD (2018).

4. Kaplan & Sadock’s Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry, 11th ed. (Philadelphia: Lippincott Williams & Wilkins, 2015, pp. 139-45).

5. Lewis’sChild and Adolescent Psychiatry: A Comprehensive Textbook, 5th ed. (Philadelphia: Lippincott Williams & Wilkins, 2017, pp. 111-22).

6. Berlin EA, Fowkes WA Jr.A teaching framework for cross-cultural health care. Application in family practice. West J Med 1983;139(6):934-8.

7. Paediatr Child Health. 2018 Feb;23(1):66-9.

Adam is a 14-year-old who presents for “behavioral concerns” as recommended by his teacher. He is in the eighth grade and is struggling academically and socially. He has intermittent outbursts and poor engagement with other children, and often refuses to do schoolwork. He is seen in the outpatient primary care clinic, usually with his mother and two older siblings, one of whom typically translates for his Arabic-speaking mother. Adam is bilingual, although he prefers Arabic. It is difficult to understand the presenting concern as Adam states that he is doing well and is unsure why the teacher would have made such a report. Mother notes that she does not see these behaviors at home either.

What must we consider? Are there potential barriers, alternate ways to engage, and what role may culture have?

There are many things to consider in the above case, including language barriers, nuanced interactions, and cultural expectations and norms. To understand the scope, statistics reveal that the United States leads the world in its immigrant population with about 44.8 million foreign-born persons in 2018, which accounts for approximately 13.7% of the U.S. population.¹ In 2019, 30,000 refugees were resettled in the United States.² In 2017, immigrant children made up 27% (19.6 million) of U.S. children, of which second-generation children (born in the United States to immigrant parents) were the vast majority at 16.7 million.³ Given this information, it is self-evident that we live in a multicultural society; it is imperative to consider the cultural context in which our patients and families are presenting.

FatCamera/E+

Culture is defined as a set of shared beliefs, norms, values, and behaviors exhibited by a group. Culture plays a role and impacts children in various ways throughout their development. Health care providers would benefit from aspiring to exude cultural humility – learning with and from patients and their families with openness, kindness, and a desire for collaboration. The provider also must consider a family’s history of migration as the response to migration may vary based on age, personal experiences, age at which migration occurred, language abilities, and amount of cultural engagement in the new country (i.e. acculturation).^4,5
 

Cultural framework model

One example of a potential framework to use to engage within a cultural context includes the LEARN (Listen, Explain, Acknowledge, Recommend, Negotiate) model,^6,7 which initially was developed to be used within a family medicine clinic. It includes the following:

Listen with sympathy and understanding to the patient’s perception of the problem. Try to understand their perspective of symptoms through considering their thoughts regarding etiology and treatment options.

Explain your perception of the problem. Have a dialogue about what you perceive is the likely cause based on a medical perspective.

Acknowledge and discuss the differences and similarities. Engage in open conversation while being cognizant that there may be similarities and differences in the perception you may have versus your patient’s perception. Try to find areas that can be engaged in and an alliance built upon, as well as respectfully and humbly addressing any concerns about potentially harmful patient understandings.

Recommend treatment. Present a treatment recommendation that considers both yours and the patient’s perspectives.

Negotiate agreement. Discuss, collaborate, and finalize a treatment plan that considers a biopsychosocial and spiritual/religious model of care that is patient-centered and personalized such that the main goal is optimal health and wellness for the patient/family.

The following are tips to consider in the life-long process of becoming more culturally aware:

• Be willing to learn with your patients and be thoughtful about your own feelings/thoughts/behaviors that may be positively or negatively impacting those interactions.
• Be aware of your own identity and what that may contribute to the clinical space.
• Recognize that you are not meant to know everything, but being open to the journey and learning process will go a long way.
• Try to shift the focus from paternalistic medicine to collaborative and patient-centered approaches.

The case at hand

In returning to our case and applying the LEARN model and cultural humility, we may be able to uncover more of the story. Adam is seen at a subsequent appointment, and you determine it best to obtain an in-person interpreter for this appointment. As you listen to the story, you learn that his father was killed early in Adam’s life, his mother has suffered from depression, and they moved here 3 years ago from a refugee camp, where most of their family continues to reside. He notes that at times he feels that he is back in that space and that he also feels frustrated. He is accustomed to doing well academically, but English has been difficult to learn.

You explain your understanding and acknowledge concerns for his past experiences playing a role, the importance of having community supports, and that learning a new language is challenging. You recommend that the school offer culturally appropriate interventions, trauma-informed assessments, and English-language opportunities. Adam and his mother note willingness to engage in this plan but would like to speak to their local religious leader as well.

Collaborating in a manner similar to this will likely build a therapeutic alliance between the patient, their family, and caretakers, thus leading to improved outcomes.

For further reading, consider AACAP Finding Mental Healthcare for Children of Immigrants and the American Academy of Pediatrics Providing Culturally Effective Care Toolkit.
 

Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. “Key findings about U.S. immigrants.” Pew Research Center, Washington, D.C. (2020)

2. “Key facts about refugees to the U.S.” Pew Research Center, Washington, D.C. (2019)

3. “Immigrant Children.” Child Trends, Bethesda, MD (2018).

4. Kaplan & Sadock’s Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry, 11th ed. (Philadelphia: Lippincott Williams & Wilkins, 2015, pp. 139-45).

5. Lewis’sChild and Adolescent Psychiatry: A Comprehensive Textbook, 5th ed. (Philadelphia: Lippincott Williams & Wilkins, 2017, pp. 111-22).

6. Berlin EA, Fowkes WA Jr.A teaching framework for cross-cultural health care. Application in family practice. West J Med 1983;139(6):934-8.

7. Paediatr Child Health. 2018 Feb;23(1):66-9.

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.

“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.

In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.

Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.

The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.

It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.

“This interpersonal loss on a massive scale is compounded by societal disruption,” they wrote. The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.

“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.

“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.

As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.

The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.

How will the United States manage this impending wave of mental health problems?

“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.

“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.

Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
 

A version of this article originally appeared on Medscape.com.

The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.

“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.

In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.

Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.

The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.

It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.

“This interpersonal loss on a massive scale is compounded by societal disruption,” they wrote. The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.

“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.

“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.

As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.

The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.

How will the United States manage this impending wave of mental health problems?

“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.

“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.

Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
 

A version of this article originally appeared on Medscape.com.

The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.

“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.

In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.

Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.

The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.

It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.

“This interpersonal loss on a massive scale is compounded by societal disruption,” they wrote. The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.

“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.

“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.

As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.

The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.

How will the United States manage this impending wave of mental health problems?

“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.

“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.

Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
 

A version of this article originally appeared on Medscape.com.

Masks, it seems, are effective at blocking the transmission of coronavirus. They’re also pretty good at stultifying consonants. For those specialties not accustomed to wearing a mask all day, it’s frustrating: How many times have you had to repeat yourself today? Or ask your patient to say something again? (Ain’t no one got time to repeat a third time how to do that prednisone taper). Worse, we’re losing important nonverbal cues that help us connect with our patients. How can we be understood when our faces are covered and 6 feet away?

Masks muffle both verbal and nonverbal communication. For soft-spoken or high-pitched speakers, the verbal effect is significant. In particular, masks make hearing consonants more difficult. They can make the “sh,” “th,” “f,” and “s” sounds difficult to distinguish. Typically, we’d use context and lip reading to boost the signal, but this fix is blocked (and the clear mouth-window masks are kinda creepy). 

Masks also prevent us from seeing facial microexpressions, critical information when you are trying to connect with someone or to build trust. A randomized controlled trial published in 2013 indeed showed that doctors wearing a mask were perceived as less empathetic and had diminished relational continuity with patients as compared to doctors not wearing a mask. There are a few things we can do to help. 

Speak more loudly is obvious advice. Loud talking has limitations though, as it can feel rude, and it blunts inflections, which add richness and emotion. (Shouting “THIS WILL ONLY HURT A LITTLE” seems a mixed message). More important than the volume is your choice of words. Try to use simple terms and short sentences. Pause between points. Hit your consonants harder. 

It’s also important that you have their full attention and are giving yours. As much as possible, try to align squared up with patients. Facing your computer exacerbates the problem. Look them in their eyes and be sure they are connected with you before any complex or difficult conversations. Hearing-impaired patients are now sometimes leaving out their aids because it’s too uncomfortable to wear them with their mask. You might ask them to put them back in. Check in with patients and repeat back what you heard them say. This can help with clarity and with connecting. Use your face more: if you’ve ever acted on stage, this would be your on-stage face. Exaggerate your expressions so it’s a little easier for them to read you. 

Lastly, there are apps such as Ava or Google Live Translator, which can transcribe your speech real time. You could then share your screen with the patient so they can read exactly what you’ve said. 

Some of us are natural communicators. Even if you are not, you can mitigate some of our current challenges. I’ll admit, it’s been a bit easier for me than for others. Between my prominent eyebrows and Italian-American upbringing, I can express my way through pretty much any face covering.  If you’d like to learn how to use your hands better, then just watch this little girl: https://youtu.be/Z5wAWyqDrnc.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Masks, it seems, are effective at blocking the transmission of coronavirus. They’re also pretty good at stultifying consonants. For those specialties not accustomed to wearing a mask all day, it’s frustrating: How many times have you had to repeat yourself today? Or ask your patient to say something again? (Ain’t no one got time to repeat a third time how to do that prednisone taper). Worse, we’re losing important nonverbal cues that help us connect with our patients. How can we be understood when our faces are covered and 6 feet away?

Masks muffle both verbal and nonverbal communication. For soft-spoken or high-pitched speakers, the verbal effect is significant. In particular, masks make hearing consonants more difficult. They can make the “sh,” “th,” “f,” and “s” sounds difficult to distinguish. Typically, we’d use context and lip reading to boost the signal, but this fix is blocked (and the clear mouth-window masks are kinda creepy). 

Masks also prevent us from seeing facial microexpressions, critical information when you are trying to connect with someone or to build trust. A randomized controlled trial published in 2013 indeed showed that doctors wearing a mask were perceived as less empathetic and had diminished relational continuity with patients as compared to doctors not wearing a mask. There are a few things we can do to help. 

Speak more loudly is obvious advice. Loud talking has limitations though, as it can feel rude, and it blunts inflections, which add richness and emotion. (Shouting “THIS WILL ONLY HURT A LITTLE” seems a mixed message). More important than the volume is your choice of words. Try to use simple terms and short sentences. Pause between points. Hit your consonants harder. 

It’s also important that you have their full attention and are giving yours. As much as possible, try to align squared up with patients. Facing your computer exacerbates the problem. Look them in their eyes and be sure they are connected with you before any complex or difficult conversations. Hearing-impaired patients are now sometimes leaving out their aids because it’s too uncomfortable to wear them with their mask. You might ask them to put them back in. Check in with patients and repeat back what you heard them say. This can help with clarity and with connecting. Use your face more: if you’ve ever acted on stage, this would be your on-stage face. Exaggerate your expressions so it’s a little easier for them to read you. 

Lastly, there are apps such as Ava or Google Live Translator, which can transcribe your speech real time. You could then share your screen with the patient so they can read exactly what you’ve said. 

Some of us are natural communicators. Even if you are not, you can mitigate some of our current challenges. I’ll admit, it’s been a bit easier for me than for others. Between my prominent eyebrows and Italian-American upbringing, I can express my way through pretty much any face covering.  If you’d like to learn how to use your hands better, then just watch this little girl: https://youtu.be/Z5wAWyqDrnc.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Masks, it seems, are effective at blocking the transmission of coronavirus. They’re also pretty good at stultifying consonants. For those specialties not accustomed to wearing a mask all day, it’s frustrating: How many times have you had to repeat yourself today? Or ask your patient to say something again? (Ain’t no one got time to repeat a third time how to do that prednisone taper). Worse, we’re losing important nonverbal cues that help us connect with our patients. How can we be understood when our faces are covered and 6 feet away?

Masks muffle both verbal and nonverbal communication. For soft-spoken or high-pitched speakers, the verbal effect is significant. In particular, masks make hearing consonants more difficult. They can make the “sh,” “th,” “f,” and “s” sounds difficult to distinguish. Typically, we’d use context and lip reading to boost the signal, but this fix is blocked (and the clear mouth-window masks are kinda creepy). 

Masks also prevent us from seeing facial microexpressions, critical information when you are trying to connect with someone or to build trust. A randomized controlled trial published in 2013 indeed showed that doctors wearing a mask were perceived as less empathetic and had diminished relational continuity with patients as compared to doctors not wearing a mask. There are a few things we can do to help. 

Speak more loudly is obvious advice. Loud talking has limitations though, as it can feel rude, and it blunts inflections, which add richness and emotion. (Shouting “THIS WILL ONLY HURT A LITTLE” seems a mixed message). More important than the volume is your choice of words. Try to use simple terms and short sentences. Pause between points. Hit your consonants harder. 

It’s also important that you have their full attention and are giving yours. As much as possible, try to align squared up with patients. Facing your computer exacerbates the problem. Look them in their eyes and be sure they are connected with you before any complex or difficult conversations. Hearing-impaired patients are now sometimes leaving out their aids because it’s too uncomfortable to wear them with their mask. You might ask them to put them back in. Check in with patients and repeat back what you heard them say. This can help with clarity and with connecting. Use your face more: if you’ve ever acted on stage, this would be your on-stage face. Exaggerate your expressions so it’s a little easier for them to read you. 

Lastly, there are apps such as Ava or Google Live Translator, which can transcribe your speech real time. You could then share your screen with the patient so they can read exactly what you’ve said. 

Some of us are natural communicators. Even if you are not, you can mitigate some of our current challenges. I’ll admit, it’s been a bit easier for me than for others. Between my prominent eyebrows and Italian-American upbringing, I can express my way through pretty much any face covering.  If you’d like to learn how to use your hands better, then just watch this little girl: https://youtu.be/Z5wAWyqDrnc.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

The first dual-purpose, external trigeminal nerve stimulation device to treat and prevent acute migraine is now available over the counter to adults over age 18. The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.

Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.

The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.

At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.

“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.

The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.

An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.

Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.

A version of this article originally appeared on Medscape.com.

The first dual-purpose, external trigeminal nerve stimulation device to treat and prevent acute migraine is now available over the counter to adults over age 18. The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.

Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.

The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.

At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.

“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.

The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.

An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.

Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.

A version of this article originally appeared on Medscape.com.

The first dual-purpose, external trigeminal nerve stimulation device to treat and prevent acute migraine is now available over the counter to adults over age 18. The Food and Drug Administration has cleared Cefaly Dual (Cefaly Technology) which was previously available only by prescription.

Most migraines involve the trigeminal nerve, which can be accessed through the skin on the forehead. Cefaly Dual stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.

The device has two settings, ACUTE and PREVENT. In the ACUTE setting, the individual wears the device for 60 minutes at headache onset or during a migraine attack. In the PREVENT setting, the individual wears the device for 20 minutes daily to help prevent future episodes.

At the start of a session, the wearer may feel a slight tingling sensation, which gradually increases and spreads throughout the forehead and the front part of the head. After about 14 minutes, the intensity stabilizes and remains constant until the treatment session is over, according to the company. The device automatically shuts off at the end of each session. It can be used as a stand-alone option or with existing treatment, the company noted.

“For millions of people across the U.S., living with migraine pain and coping with debilitating symptoms are daily realities. It is our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half,” Jennifer Trainor McDermott, CEO of Cefaly Technology, said in a news release.

The FDA’s over-the-counter clearance of Cefaly Dual was based on several randomized, controlled clinical trials supporting the efficacy and safety of the device, the company said.

An earlier version of the Cefaly device was approved in the United States in March 2014 to help prevent migraine headache in adults aged 18 or older. The next-generation Cefaly Dual device is “small and sleek in comparison to its older model, which uses bands along the sides to create room for batteries. The newest device is palm-sized, more portable, and uses a battery that is rechargeable via USB,” the company said.

Last spring, the company announced a buyback program where customers in the United States may return their original device and receive a discount of the purchase of the Cefaly Dual device.

A version of this article originally appeared on Medscape.com.

Each year on Oct. 10, the world takes a moment to commemorate the significance of mental health and its impact on an individual’s life. This year, as we continue to reflect beyond World Mental Health Day, we see the world in a different light. Creating awareness for mental health issues and expanding access to psychiatric services has now become more essential than ever before.

The year 2020 will forever be known as the beginning of the “COVID era” as, unfortunately, the whole world as we know it adapts and reconstructs amid the rise of this global pandemic. This era has brought with it a wave of unemployment, social isolation, economic disaster, death, and disability. It is inevitable that such changes have brought forth perpetual fear and uncertainty, which have taken their toll not only on individuals’ physical health but largely on their mental health as well.

Factors that perpetuate deteriorating mental health include unemployment, poverty, isolation, fear and loss of loved ones – all of which have been further exacerbated globally, thanks to the current pandemic. According to the World Health Organization (WHO), 450 million people in the world suffer from mental illness, and one in four individuals are affected by mental illness in some stage of their lives. This means that mental illness accounts for 13% of the total global burden of disease.

The past few months have been particularly challenging for health care workers around the globe. These challenges include providing care in difficult circumstances, going to work afraid of bringing COVID-19 home, and vulnerability toward becoming mentally and physically ill. An immense sense of responsibility toward patients with mental illness, coupled with continuous fear of becoming infected with this novel virus, has made managing the mental health of our patients all the more challenging.

As a psychiatrist (A.A.M.), I have noticed a massive increase in both the incidence and prevalence of mental illness. Emergency departments are full of patients presenting with suicidal attempts/ideation. Substance abuse has increased in greater magnitude, and outpatients are presenting with escalating numbers of depression and anxiety. Relapse of symptoms among stable patients has been another major problem. Incidents of domestic violence, road rage, and impaired driving secondary to alcoholism leading to psychiatric consultations have also risen drastically.

Mental health units in hospitals are tremendously busy with scarce availability of beds. The increase in waiting times for allocation of beds has also become a major concern globally.

Governments have allocated more funds and are actively attempting to mobilize resources in the developed world. However, adapting to the circumstances has proven to be far more challenging in many regions of the developing world. To avoid personal contacts in health settings, governments have allowed virtual consultations, which has proven to be a highly commendable decision. The use of telephone and video consultations has allowed physicians, particularly psychiatrists, to continue to provide health care to their patients while maintaining social distance. Crisis services have also become far more active, which can help in alleviating mental health emergencies to a great extent.

International crisis is possible

According to the director of the World Federation for Mental Health, citing the report of World Economic Forum, mental health problems could cost the global economy up to $16 trillion between 2010 and 2030, and if this matter is not addressed, it could potentially lead to an international mental health crisis. If the pandemic continues to create such a large impact for a prolonged period of time, the state of mental health globally will continue to be a major concern.

Universal effort is imperative to strengthen the mental health service and increase our ability to provide care for vulnerable individuals. This can be achieved through collaboration with other stakeholders, the allied health sector, the WHO, and the World Bank. The efforts should be directed toward the availability of funds, mobilizing and enhancing resources and training health care and crisis workers. This focus should not only be for developed countries but also for developing countries alike because we are all suffering from the impacts of this global crisis together.

It is important to raise awareness and support one another now more than ever before as we strive to improve and strengthen our mental health on this World Mental Health Day.
 

Dr. Muhammad is clinical professor of psychiatry at McMaster University, Hamilton, Ont. Ms. Amin is a 5th-year MBBS student at St. George’s University Hospital in London.

Each year on Oct. 10, the world takes a moment to commemorate the significance of mental health and its impact on an individual’s life. This year, as we continue to reflect beyond World Mental Health Day, we see the world in a different light. Creating awareness for mental health issues and expanding access to psychiatric services has now become more essential than ever before.

The year 2020 will forever be known as the beginning of the “COVID era” as, unfortunately, the whole world as we know it adapts and reconstructs amid the rise of this global pandemic. This era has brought with it a wave of unemployment, social isolation, economic disaster, death, and disability. It is inevitable that such changes have brought forth perpetual fear and uncertainty, which have taken their toll not only on individuals’ physical health but largely on their mental health as well.

Factors that perpetuate deteriorating mental health include unemployment, poverty, isolation, fear and loss of loved ones – all of which have been further exacerbated globally, thanks to the current pandemic. According to the World Health Organization (WHO), 450 million people in the world suffer from mental illness, and one in four individuals are affected by mental illness in some stage of their lives. This means that mental illness accounts for 13% of the total global burden of disease.

The past few months have been particularly challenging for health care workers around the globe. These challenges include providing care in difficult circumstances, going to work afraid of bringing COVID-19 home, and vulnerability toward becoming mentally and physically ill. An immense sense of responsibility toward patients with mental illness, coupled with continuous fear of becoming infected with this novel virus, has made managing the mental health of our patients all the more challenging.

As a psychiatrist (A.A.M.), I have noticed a massive increase in both the incidence and prevalence of mental illness. Emergency departments are full of patients presenting with suicidal attempts/ideation. Substance abuse has increased in greater magnitude, and outpatients are presenting with escalating numbers of depression and anxiety. Relapse of symptoms among stable patients has been another major problem. Incidents of domestic violence, road rage, and impaired driving secondary to alcoholism leading to psychiatric consultations have also risen drastically.

Mental health units in hospitals are tremendously busy with scarce availability of beds. The increase in waiting times for allocation of beds has also become a major concern globally.

Governments have allocated more funds and are actively attempting to mobilize resources in the developed world. However, adapting to the circumstances has proven to be far more challenging in many regions of the developing world. To avoid personal contacts in health settings, governments have allowed virtual consultations, which has proven to be a highly commendable decision. The use of telephone and video consultations has allowed physicians, particularly psychiatrists, to continue to provide health care to their patients while maintaining social distance. Crisis services have also become far more active, which can help in alleviating mental health emergencies to a great extent.

International crisis is possible

According to the director of the World Federation for Mental Health, citing the report of World Economic Forum, mental health problems could cost the global economy up to $16 trillion between 2010 and 2030, and if this matter is not addressed, it could potentially lead to an international mental health crisis. If the pandemic continues to create such a large impact for a prolonged period of time, the state of mental health globally will continue to be a major concern.

Universal effort is imperative to strengthen the mental health service and increase our ability to provide care for vulnerable individuals. This can be achieved through collaboration with other stakeholders, the allied health sector, the WHO, and the World Bank. The efforts should be directed toward the availability of funds, mobilizing and enhancing resources and training health care and crisis workers. This focus should not only be for developed countries but also for developing countries alike because we are all suffering from the impacts of this global crisis together.

It is important to raise awareness and support one another now more than ever before as we strive to improve and strengthen our mental health on this World Mental Health Day.
 

Dr. Muhammad is clinical professor of psychiatry at McMaster University, Hamilton, Ont. Ms. Amin is a 5th-year MBBS student at St. George’s University Hospital in London.

Each year on Oct. 10, the world takes a moment to commemorate the significance of mental health and its impact on an individual’s life. This year, as we continue to reflect beyond World Mental Health Day, we see the world in a different light. Creating awareness for mental health issues and expanding access to psychiatric services has now become more essential than ever before.

The year 2020 will forever be known as the beginning of the “COVID era” as, unfortunately, the whole world as we know it adapts and reconstructs amid the rise of this global pandemic. This era has brought with it a wave of unemployment, social isolation, economic disaster, death, and disability. It is inevitable that such changes have brought forth perpetual fear and uncertainty, which have taken their toll not only on individuals’ physical health but largely on their mental health as well.

Factors that perpetuate deteriorating mental health include unemployment, poverty, isolation, fear and loss of loved ones – all of which have been further exacerbated globally, thanks to the current pandemic. According to the World Health Organization (WHO), 450 million people in the world suffer from mental illness, and one in four individuals are affected by mental illness in some stage of their lives. This means that mental illness accounts for 13% of the total global burden of disease.

The past few months have been particularly challenging for health care workers around the globe. These challenges include providing care in difficult circumstances, going to work afraid of bringing COVID-19 home, and vulnerability toward becoming mentally and physically ill. An immense sense of responsibility toward patients with mental illness, coupled with continuous fear of becoming infected with this novel virus, has made managing the mental health of our patients all the more challenging.

As a psychiatrist (A.A.M.), I have noticed a massive increase in both the incidence and prevalence of mental illness. Emergency departments are full of patients presenting with suicidal attempts/ideation. Substance abuse has increased in greater magnitude, and outpatients are presenting with escalating numbers of depression and anxiety. Relapse of symptoms among stable patients has been another major problem. Incidents of domestic violence, road rage, and impaired driving secondary to alcoholism leading to psychiatric consultations have also risen drastically.

Mental health units in hospitals are tremendously busy with scarce availability of beds. The increase in waiting times for allocation of beds has also become a major concern globally.

Governments have allocated more funds and are actively attempting to mobilize resources in the developed world. However, adapting to the circumstances has proven to be far more challenging in many regions of the developing world. To avoid personal contacts in health settings, governments have allowed virtual consultations, which has proven to be a highly commendable decision. The use of telephone and video consultations has allowed physicians, particularly psychiatrists, to continue to provide health care to their patients while maintaining social distance. Crisis services have also become far more active, which can help in alleviating mental health emergencies to a great extent.

International crisis is possible

According to the director of the World Federation for Mental Health, citing the report of World Economic Forum, mental health problems could cost the global economy up to $16 trillion between 2010 and 2030, and if this matter is not addressed, it could potentially lead to an international mental health crisis. If the pandemic continues to create such a large impact for a prolonged period of time, the state of mental health globally will continue to be a major concern.

Universal effort is imperative to strengthen the mental health service and increase our ability to provide care for vulnerable individuals. This can be achieved through collaboration with other stakeholders, the allied health sector, the WHO, and the World Bank. The efforts should be directed toward the availability of funds, mobilizing and enhancing resources and training health care and crisis workers. This focus should not only be for developed countries but also for developing countries alike because we are all suffering from the impacts of this global crisis together.

It is important to raise awareness and support one another now more than ever before as we strive to improve and strengthen our mental health on this World Mental Health Day.
 

Dr. Muhammad is clinical professor of psychiatry at McMaster University, Hamilton, Ont. Ms. Amin is a 5th-year MBBS student at St. George’s University Hospital in London.